MAUDE Adverse Event Report: COOK INC FLEXOR SHUTTLE SELECT GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Codes	Split (2537); Difficult to Advance (2920)
Health Effect - Clinical Code	Death (1802)
Date of Event	01/21/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Event is still under investigation.
Event or Problem Description
Initial information stated that advancement difficulty was experienced during the procedure of recanalisation of a.Carotis interna and a cerebri media.At this time, it was noted the introducer was cracked.Additional information was provided stating that placement of the cook shuttle sheath in left common carotid artery via terumo stiff wire(.035) via another manufacturer's 5f/ 130 cm catheter.During the intervention, it was noted that, following the stenting of the carotid artery, the sheath could not be guided further in the distal direction (not an unusual occurrence in the case of elongations) and that the dilatation balloon (following the implantation of the stent) showed signs of increased friction while being withdrawn through the sheath.Other materials (another manufacturer's catheter, etc.) were guided through the sheath without problems.There was no dislocation of the sheath into the aortic arch through kickback at any time.No forced manipulations.It was advised that the sheath damage was discovered following completion of the intervention and removal of the sheath from the patient when changing to a short size 7f sheath (in order to use the exoseal closing system).There was a sheath fracture without a "hole" in the sheath wall (verified by injection of fluid).Sheath fractured approx.13 cm proximal from the distal sheath opening.No immediate consequences to the patient during therapy.Patient died later (on an unknown time), as a result of a hemorrhagic infarction (not related to this intervention).
Additional Manufacturer Narrative
A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.One flexor shuttle select guiding sheath was returned for evaluation.The sheath was separated at 11.5 cm from the distal tip with the coil still attached.No frayed ends or stretching was noted.The dilator was not returned.While patient death was reported in this case, the physician stated that the patient death was not related to the intervention.Autopsy results were requested numerous times to aid in the investigation of this event; they were not provided.There is no evidence to suggest the product was not made to specifications.Review of the device history record shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.Based on the information provided and the results of our investigation; a definitive root cause could not be determined.

• Brand Name: FLEXOR SHUTTLE SELECT GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6314111
• Report Number: 1820334-2017-00271
• Device Sequence Number: 737282
• Product Code: DYB
• UDI-Device Identifier: 00827002311381
• UDI-Public: (01)00827002311381(17)191128(10)7471180
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KSAW-6.0-38-90-RB-SHTL-FLEX-HC
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2017
• Supplement Report FDA Received Date: 04/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 76 YR